X-Pac

FDA UDI

Class I (US FDA UDI)

by Expanding Innovations, Inc.

Identity

Trade Name: X-PAC FDA UDI
Generic Name: Scalpel handle, reusable FDA UDI
Device Name: Scalpel Handle, Long FDA UDI
Model / Reference: EI3920 FDA UDI
Description: Scalpel Handle, Long FDA UDI

Identifiers

Primary DI / UDI-DI: 00810166521307 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Scalpel handle, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Scalpel handle, reusable

X-Pac by Expanding Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Surgical Direct — SURGICAL DIRECT, INC. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Anterior Disc Prep — SeaSpine Orthopedics Corporation · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
Brasseler USA — Peter Brasseler Holdings, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Expanding Innovations, Inc.

Sources (1)

FDA UDI e4dd64f2-b459-418b-a081-e4b13318e2c7 34 fields · synced May 30, 2026